Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06702722

Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial

Led by University of North Carolina, Chapel Hill · Updated on 2026-04-29

400

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi. This fully powered randomized controlled trial aims to confirm the intervention's effectiveness, study how it works, and gather important data to help apply the findings in real-world settings. The study follows up on a pilot trial that showed promising results for improving mental health and HIV care during and after pregnancy. Participants will receive either the Enhanced Friendship Bench intervention or enhanced usual care. The Enhanced Friendship Bench includes problem-solving therapy with four prenatal and two postnatal counseling sessions, two social support sessions, and monthly home visits for ART delivery and counseling during the third trimester and first three months postpartum. The comparison group will receive usual outpatient care enhanced with mental health evaluations, brief counseling, education about mental health, and referral support when needed. Throughout the study, participants will be monitored for changes in depressive symptoms and HIV care retention six months after giving birth. Infant growth measurements will also be taken at six months postpartum, including height-for-age, weight-for-age, and weight-for-height. Additional assessments include depression remission and HIV viral suppression up to twelve months postpartum. The study uses double-masked methods and randomizes participants to either group, with ongoing evaluations to track health outcomes and treatment engagement over time.

CONDITIONS

Brief Title

Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Presenting for antenatal care at one of the recruitment sites
  • 18 years of age or older
  • 34 weeks gestation or less
  • HIV-positive based on medical records
  • Initiating, re-initiating, or on established ART during current pregnancy
  • Elevated depressive symptoms indicated by EPDS score of 10 or higher
Not Eligible

You will not qualify if you...

  • Suicidal ideation evaluated as acute risk
  • Other health concerns requiring emergent response

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - From 3rd trimester through 3 months postpartum

Participants receive Enhanced Friendship Bench therapy including 4 prenatal and 2 postnatal counseling sessions, 2 social support sessions, and monthly home visits for ART delivery and counseling during the 3rd trimester and first 3 months postpartum, or enhanced usual care involving mental health evaluation, brief supportive counseling, and referral support.

Monthly home visits and counseling sessions during treatment period

Follow-up

Duration - Up to 12 months postpartum

Participants are monitored for mental health, HIV care retention, and infant growth outcomes up to 6 to 12 months postpartum.

Assessments at 6 and 12 months postpartum

Trial Site Locations

Total: 5 locations

1

Area 18 Health Center

Lilongwe, Malawi

Not Yet Recruiting

2

Area 25 Health Center

Lilongwe, Malawi

Actively Recruiting

3

Bwaila Hospital

Lilongwe, Malawi

Actively Recruiting

4

Kawale Health Center

Lilongwe, Malawi

Actively Recruiting

5

Likuni Mission Hosptial

Lilongwe, Malawi

Actively Recruiting

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Research Team

B

Brian Pence, PhD, MPH

A

Angela Bengtson, PhD, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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